Valve holder

ABSTRACT

A valve holder assembly having a main valve holder and a detachable secondary valve holder for positioning a heart valve prosthesis and a method of implanting a stentless heart valve prosthesis are disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of Ser. No. 11/102,345 filed Apr. 8,2005 which claims the benefit of Provisional Application Ser. No.60/561,746 filed Apr. 13, 2004, the entireties of which is herebyincorporated by reference.

FIELD OF THE INVENTION

This invention relates to devices and surgical procedures utilized forholding a stentless heart valve prosthesis during implantation.

DISCUSSION OF THE PRIOR ART

Heart valve replacement is required when a patient's heart valve becomesdiseased or damaged. Surgically-implanted hearted valve prostheses haveextended the life expectancy of many patients who had defective naturalvalves. Such prostheses can be either mechanical or biological (mitralor aortic). The aortic prosthesis is implanted in the patient during asurgical procedure in which a segment of the aorta nearby the naturalvalve is slit open so that the malfunctioning valve can be removed andreplaced with the prosthetic valve. The prosthetic valve must be held inplace while the surgeon sutures or attaches the prosthetic heart valveto the annulus of the heart. Holding the implant in place while thesurgeon places the sutures to attach it to the interior of the patient'saorta presents a difficult problem, due to the limited amount of spacein the heart it is difficult to properly position and suturing the valveat the site of the annulus. To aid the surgeon during the implantprocedure, it is known to use both disposable and non-disposable holdersto position the valve during surgery. However, the known valve holdersare large and cumbersome. These known valve holders are also unwieldyand obstruct the surgeon's view.

During this surgical procedure, the heart is typically stopped, and thepatient put on heart/lung bypass. The longer a patient is required torely on the artificial heart/lung bypass to maintain vital functions,the greater the stress on the patient. Thus there is a need to simplifythe suturing of the heart valve prosthesis to the aorta in order tominimize both the length of surgery and the amount of time spent onheart/lung bypass.

Bioprosthesis from animal donors, such as those made of equine tissue,are flexible and are often supported by mechanical stents. A typicalstented heart valve is disclosed in Duran, Reed Valve for Implantationinto Mammalian Blood Vessels and Heart with Optional Temporary orPermanent Support, US 2005/0055079 A1. However, such stents occupy spacewithin the aorta of the patients and may produce undesirable turbulence.Thus, there is a need to improve the suturing of a stentless heart valveprosthesis. Further, the positioning and alignment of the valveprosthesis to closely match that of the natural valve requires precisionsuturing.

The lack of a stent and easily pliable tissue material makesimplantation of stentless valve difficult and time consuming. Thestentless valves are very pliable and suturing and adequate positioningof the valve is very difficult. Several assistants are usually needed toholder the stentless valve in position with fingers, forceps orhemostats. This procedure is awkward for both the assistants and thesurgeon performing the suturing. It is clearly advantageous to performthe valve surgery quickly as possible and to ensure symmetrical suturingand accurate placement of the prosthesis.

SUMMARY OF THE INVENTION

The invention relates to an improved valve holder assembly to positionand hold a stentless valve prosthesis. A suitable stentless heart valveprosthesis is that of Myers et al., Prosthetic Heart Valve, U.S. Pat.No. 6,682,559, hereby incorporated by reference. The valve holderassembly has a main valve holder that is open and generally cylindrical.This main valve holder has a top member, adapted to receive a handle, agenerally cylindrical main valve holder ring base, and support membersconnecting the top and base. The valve holder assembly further includesa removable secondary valve holder that includes three collapsiblecommissural posts radiating outwardly. The secondary valve holder isadapted to nest within the hollow space of the main valve holder and hassubstantially the same centerline as the main valve holder. Thesecondary valve holder has a top member allowing for removablyconnecting the secondary valve holder to the main valve holder. Theinvention includes a rigid, hollow, generally cylindrical and open mainvalve holder having a top member adapted to receive a main valve holderhandle, a generally cylindrical main valve holder ring base, and supportmembers connecting the main valve holder top member and the ring base,the main valve holder adapted to hold a prosthetic valve. A removablesecondary valve holder nests within the hollow space of the generallycylindrical main valve holder and has substantially the same centerlineas the main valve holder. The secondary valve holder includes a flat,disc-shaped secondary valve holder top member removably connected to themain valve holder top member; a rotational axel coupled to saidsecondary valve holder top member; and three elongated commissural postsextending radially from said top member and rotational axel along asubstantially horizontal axis thereof. The commissural posts arestructured to collapse from a position along the horizontal axis to aposition along a substantially vertical axis. The commissural posts areadapted to position the prosthetic valve during surgical implantation.

The invention provides a valve holder assembly that is securely attachedto a prosthetic valve and allows the surgeon or surgeon assistants toeasily manipulate the valve holder assembly so that the inflow portionof the suture ring of the replacement valve is properly aligned with theaortic annulus and to ensure symmetrical suturing and accurate placementof the prosthesis commissural post tabs to the aortic wall. First, thesurgeon loosely sutures the suture ring of the replacement valve to theaortic annulus and then can lower the valve with the holder into theaortic wall to the aortic annulus. Next, the main valve holder is thendetached from the prosthetic valve by easily pulling away cutting thetemporary assembling sutures from the attached prosthetic heart valve,leaving the secondary holder in place attached to the valve from thethree prosthesis commissural suture tabs. Next, the retractable holderis collapsed. As a result, the suture ring of the prosthetic heart valveis sutured into the aortic annulus and remains unobstructed to thesurgeons to tie the sutures. Next, the retractable secondary holder ispulled up in a straight line and the valve is aligned with the suturetabs in symmetrical suturing placement. The commissural tabs arereleased by cutting the assembling sutures from the secondary holder oneby one and sewn to the aortic wall. Finally, the secondary retractableholder is released and removed from surgical field. An alternative tothe last step is to do the first suture to the top of each of the suturetabs, release the secondary holder and then finish the suturing asnecessary.

With the utilization of the above mentioned instrument, surgicalprocedures involving the implant of stentless heart valves are lesscomplicated and can be performed faster.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of the valve holder assembly.

FIG. 2 is a side view of the valve holder assembly.

FIG. 3 is a top view of the secondary valve holder with a heart valveprosthesis mounted therewithin.

FIG. 4 is a slide view of the valve, already sutured to the aorticannulus and partially collapsed secondary valve holder.

FIG. 5 is a side view of the fully extended secondary valve holder andstentless heart valve prosthesis along the aortic wall.

FIG. 6 is a side view of a stentless heart valve prosthesis sutured tothe aortic annulus, the commissural post tabs sutured to the aortic walland the secondary valve holder removed.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in FIG. 1 and FIG. 2, the present invention is directed to avalve holder assembly 1, having a main valve holder 3 and a retractableor removable secondary valve holder 5 within which is positioned astentless heart valve prosthesis 7. The main valve holder 3 is generallycylindrical and open or hollow with a main valve holder top member 9,adapted at hole 11, preferably threaded, to receive a handle 13 as shownin FIG. 2. The main valve holder 3 has narrow strut support members 19.Preferably, the main valve holder base 17 is scalloped as the valve ofU.S. Pat. No. 6,682,559 is scalloped. The stentless prosthetic heartvalve 7 includes a prosthetic heart valve suture ring 21 to which mainvalve holder assembly sutures 23 may be used to secure the prostheticheart valve suture ring 21 to the main valve holder 3. Further,secondary holder valve assembling sutures 25 may be employed to securethe main valve holder 3 to the secondary valve holder 5.

The heart valve prosthesis 7 includes commissural valve tabs 27 securedto the secondary heart valve holder 5. As shown in FIG. 1 and FIG. 2,the main valve holder 3 and the secondary valve holder 5 havesubstantially the same centerline 29. And the secondary valve holder 5is adapted to removably nest within the main valve holder 3. As showngenerally in FIGS. 1, 2 and 3 the heart valve prosthesis 7 includes arigid, hollow, generally cylindrical and open main valve holder 3 havinga top member 9 adapted to receive a main valve holder handle 13, agenerally cylindrical main valve holder ring base 17, and supportmembers connecting the main valve holder top member and the ring base19. The main valve holder 3 is adapted to hold a prosthetic valve 7. Aremovable secondary valve holder 5 nests within the hollow space of thegenerally cylindrical main valve holder 3 and has substantially the samecenterline as the main valve holder 3. The secondary valve holder 5includes a flat, disc-shaped secondary valve holder top member 31removably connected to the main valve holder top member 9; a rotationalaxel 15 coupled to said secondary valve holder top member 31; and threeelongated commissural posts 35 extending radially from said top member31 and rotational axel 15 along a substantially horizontal axis thereof.The commissural posts 35 are structured to collapse from a positionalong the horizontal axis to a position along a substantially verticalaxis.

Turning now to FIG. 3 and FIG. 4, the secondary valve holder 5 has asecondary valve top member 31 and three collapsible commissural posts 35preferably spaced 120 degree. from each other and adapted to flex aboutrotational axle 15. In FIGS. 3 and 4, the main valve holder 3 has beenremoved. FIG. 4 shows the secondary valve holder 5 and the stentlessheart valve prosthesis 7 in the partially collapsed position.

FIG. 5 shows the secondary valve holder 5 in its extended ornon-collapsed position. The commissural post valve tabs 27 can besutured to the aortic wall 37 by means of sutures 39.

FIG. 6 shows the stentless heart valve prosthesis 7 sutured to theaortic wall 37, with the secondary valve holder 5 removed, and thesuture ring sutured to the aortic annulus 41.

Having described the structure of the valve holder of this invention,its method of use will now be discussed.

The valve holder assembly 1, including main valve holder 3, secondaryvalve holder 5 and stentless heart valve prosthesis 7 is employed forimplantation as shown in FIG. 1 and FIG. 2 following removal of apatient's diseased or damaged natural heart valve. FIG. 4-FIG. 6illustrates the implantation of the stentless heart valve prosthesis 7after suturing the valve suture ring 21 to the aortic annulus 41, andremoval of the main valve holder 3 by cutting main valve holderassembling sutures 23. FIG. 4 illustrates the secondary valve holder 5and the stentless heart valve prosthesis 7 in the partially collapsedposition, allowing the surgeon or technician to tie the suture of thestentless heart valve prosthesis suturing 21 to the aortic annulus 41.Secondary valve holder 5 may be collapsed by pressing secondary valveholder handle 43.

FIG. 5 illustrates the secondary valve holder 5 in the uncollapsed orfully extended implanting position, and one of the three commissuralvalve tabs 27 removed from the secondary valve holder 5 and sutured tothe aortic wall 37. Finally, in FIG. 6, the commissural valve tabs 27have been sutured to the aortic wall 37, and the secondary valve holder5, that in effect acts as a temporary stent during the implantationprocedure only, removed.

The holder of the present invention may be made of metal or otherplastic materials that can be cleaned or sterilized in an autoclave, asit is well known by those skilled in the art. In another embodiment, theholder is made of plastic and, thus be disposable. Obviously, numerousvariations and modifications can be made within departing from thespirit of the present invention. Therefore, it should be clearlyunderstood that the forms of the present invention described above andshown in the figures of the accompanying drawings are illustrative onlyand are not intended to limit the scope of the present invention.

1. A method of implantation of a stentless heart valve prosthesiscomprising: positioning a stentless heart valve prosthesis within asecondary heart valve holder, that is nested within a main valve holder;suturing a suture ring of the stentless heart valve prosthesis to anaortic annulus; removing the main valve holder; collapsing the secondaryvalve holder and stentless heart valve prosthesis and tying the suturessecuring the suture ring of the stentless heart valve prosthesis to theaortic annulus; extending the secondary valve holder and stentless heartvalve prosthesis to an uncollapsed position; suturing the stentlessheart valve prosthesis to the aortic wall; and removing the secondaryvalve holder.
 2. The method claimed in claim 1, further comprisingsuturing the stentless heart valve prosthesis to the aortic wall atthree commissural posts.